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A posthoc analysis of the phase 2 CANDELA study presented at ARVO 2023 suggests aflibercept 8 mg improved visual and anatomical outcomes compared with aflibercept 2 mg in eyes with nAMD.
Eyes with neovascular age-related macular degeneration (nAMD) treated with aflibercept 8 mg achieved improvements in visual and anatomic outcomes, according to findings from the phase 2 CANDELA study.1
The research, presented at the 2023 Association for Research in Vision and Ophthalmology (ARVO) 2023 Annual Meeting in New Orleans, Louisiana, suggests the potential therapeutic benefit of high-dose aflibercept compared with aflibercept 2 mg in eyes with nAMD.
“In the results, the primary issue is safety,” presenting author Jordana Goren Fein, MD, Retina Group of Washington, told HCPLive at ARVO 2023. “We’re very excited to report that there were no new safety signals between the 8 mg and standard 2 mg aflibercept. Additionally, there was a significant trend towards both drying as well as visual acuity outcomes in the high dose aflibercept arm versus the standard two milligram arm.”
The CANEDLA study examined the effect of intravitreal aflibercept 8 mg injection on visual and anatomic outcomes in treatment-naive patients with nAMD. Patients were randomized to receive 3 monthly doses of either aflibercept 2 mg (n = 53) or aflibercept 8 mg (n = 53) followed by doses at Weeks 20 and 32.
The post-hoc analysis was conducted to assess the proportion of eyes without intraretinal fluid (IRF), subretinal fluid (SRF), or sub-retinal pigment epithelium (RPE) fluid in the central subfield at Weeks 16 and 44. Additionally, the study assessed the proportion of eyes that achieved >239 µm reduction in central subfield thickness (CST), ≥15-letter gain, best-corrected visual acuity (BCVA) ≥20/40, and BCVA ≥20/20 at Week 44, and the proportion of eyes with baseline BCVA <20/40 that achieved ≥10- and ≥15-letter gains at Week 44.
Upon analysis, the proportion of eyes treated with aflibercept 8 mg without IRF, SRF, or sub-RPE fluid in the central subfield was 38%, compared with 19% of eyes treated with aflibercept 2 mg (nominal P = .031). The analysis indicated the proportion was 25% versus 11% at Week 44 (nominal P = .076).
Moreover, the analysis showed a greater proportion of eyes had >239 µm reduction in CST with aflibercept 8 mg, compared to aflibercept 2 mg (27% vs. 20%), at Week 44. Additionally, at Week 44, a greater proportion of eyes in the aflibercept 8 mg versus 2 mg group gained ≥15-letters (33% vs. 14%), achieved BCVA ≥20/40 (61% vs. 49%), and achieved BCVA ≥20/20 (10% vs. 2%).
On the other hand, data showed a smaller proportion of eyes had vision loss or no BCVA change at Week 44 (20% vs. 27% in the aflibercept 8 mg and 2mg arms, respectively). Additionally, among eyes with baseline BCVA <20/40, a greater proportion in the aflibercept 8 mg versus 2 mg group gained ≥10 letters (65% vs. 47%), and ≥15 letters (43% vs. 18%) at Week 44.
For more perspective on the above findings, watch our interview with Fein at ARVO 2023 here:
Fein reports having received funds for consulting from Regeneron Pharmaceuticals Inc, Bausch and Lomb, Genentech/Roche, and Apellis.